Posted by Michael Wonder on 04 Aug 2020
Biosight granted U.S. FDA fast track designation for BST-236 for the treatment of acute myeloid leukaemia
4 August 2020 - Biosight today announced that that the U.S. FDA has granted fast track designation for BST-236 (aspacytarabine) for the treatment of acute myeloid leukaemia in adults who are 75 years or older, or who have co-morbidities that preclude use of intensive induction chemotherapy.
BST-236, Biosight’s lead product candidate, is a novel antimetabolite, designed to provide the benefit of intensive chemotherapy while avoiding much of its toxicity.
The company is currently enrolling patients in its Phase 2b study, evaluating BST-236 as a single-agent first-line AML therapy for patients unfit for standard chemotherapy, and recently announced a collaboration with the European cooperative group, GFM, for the initiation of a phase 2 trial of BST-236 in relapsed/refractory myelodysplastic syndrome and acute myeloid leukaemia patients, to begin in the fourth quarter of 2020.
